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skitahoe

08/06/18 6:46 PM

#185302 RE: Lykiri #185297

I believe I understand what you're saying, but how are patients treated who cross over to our drug. Do the K-M plots have a way of saying for instance 14 months after surgery a patient progressed, but crossed over and is still alive, or has passed after crossing over.

I'm of the belief that the FDA needs to recognize that any improvement, regardless of how small, should be approved to see if in combinations not tried during trials it may do substantially better. Quality of life should also be considered and I have no idea if those taking our drug are having a better, or worse quality of life. If it's better, that certainly should be a consideration, if worse, it works against us. It may be a judgement call but the clinicians should certainly be able to judge that as they learn which patients did, or didn't receive the drug from the beginning.

Gary
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sentiment_stocks

08/06/18 7:29 PM

#185311 RE: Lykiri #185297

Ok so my error is with the second group of 41.

Instead of 27, there appears to be 7, and this matches when you count up the 7 censors between month 30 and 36.

Well… I prefer the number 27 better, lol, but the fact that those 7 censors are there is hard to argue against.

Now take the second group of 41 patients (223-182). You may assume that these patients behave the same way.
That means that of these 41 patients 30% = 12 will live at least 30 months.
This group of patients had their surgery between March 15, 2014 and September 15, 2014.

Every patient who is still alive will be marked on the OS curve with a vertical line between 30 and 36 months.
If you look at the OS curve, you see 7 censors.

Conclusion: of the 12 patients who have lived for at least 30 months, 7 are still alive and 5 have died between 30 and 36 months.( 5 step downs on the curve)



So according to your thoughts, we have 51 patients from 223, as you indicated (44 + 7), and so we must rely on the remaining 108 patients to get that 22.8% up at 36 months.

Well if 31 of them were not randomized to control, that will help.

Meirluc, what are your thoughts regarding Lykiri's numbers?

Ex? Never mind, don't answer ex. No, just kidding.
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sentiment_stocks

08/08/18 5:37 PM

#185583 RE: Lykiri #185297

Hi Lykiri -

I went back and looked at the chart in the journal, and then looked over your post, and I have a few comments for you to consider.

First, I took a very careful look at the chart to break it down - looking at the step downs (deaths) and the vertical lines (censored).

I may be wrong on the step downs, but I did count every little itty bitty stagger,
and this is what I came up with.

First 12 months
7 LTFU
32 died

12 to 18 months
4 LTFU
61 died

18 to 24 months
36 censored
47 died

24 to 30 months
20 censored
24/25 died

30 to 36 months
7 censored
17 died

For a total of:

11 LTFU
182 died
64 censored

to equal 257 patients

331 - 257 = 74 patients are not on the chart


I've attached a picture that indicates this and I'm wondering of others posting here if the numbers look correct?
If there indeed 74 patients not on the chart, then we can make some assumptions, like that there were 74 patients that lived past 36 months.

Anyhow, I'd like to first see if others better suited to looking at charts like this do not agree with my numbers.